Biosimilars Gastroenterology Roundup: February 2023

As a new wave of biosimilars to treat inflammatory bowel disease— an umbrella term for Crohn disease and ulcerative colitis—enter the US market, a lot of clinical and policy news regarding adalimumab and infliximab biosimilars emerged throughout the month of February.

The Adalimumab Race Continues

On the regulatory side, Sandoz’ citrate-free high-concentration version (HCF) of Hyrimoz, a biosimilar referencing Humira (adalimumab), was granted a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use, bringing the new formulation one step closer to regulatory approval across the European Union.

If approved by the European Commission, Hyrimoz HCF will be used to treat rheumatoid arthritis (RA), Crohn disease, ulcerative colitis, plaque psoriasis, and uveitis.

In the United States, a Cardinal Health report found that over 60% of providers plan to only prescribe adalimumab biosimilars that have an interchangeability designation, signaling that providers view interchangeability designations to be significant identifiers about the safety or safety of switching to a particular biosimilars despite this not being what the label means.

Interchangeability is a regulatory designation allowing pharmacists to dispense biosimilars in place of a reference without having to wait for a physician’s approval. The report’s results contradict the global perspective on adalimumab biosimilars as the European Union and the United Kingdom have made statements declaring all biosimilars as interchangeable with their reference products. There is currently 1 adalimumab biosimilars on the US market (Amjevita) and 9 more are expected to launch in July 2023.

Industry Analysis

The IQVIA Biosimilars in the United States 2023-2027 report predicted that expected launches and increased biosimilar uptake will increase spending to $129 billion and savings by $180 billion over the next 5 years. The numbers in part will be driven by the US launches of adalimumab biosimilars and ustekinumab biosimilars.

Vizient launched its updated Pharmacy Market Outlook report, which predicted that the price of biologics will experience a 3.05% inflation rate, 3 times higher than the projected inflation rate for nonbiologic drugs. Vizient also predicted that injectable drugs, such as biologics used to treat immunology and gastroenterology conditions, will have 3.26% inflation rate, over 3 times greater than the 1.07% inflation rate predicted for non-injectable drugs.

Regarding adalimumab, Vizient predicted that adalimumab biosimilar with citrate-free and/or high-concentration formulations will obtain greater market share than other adalimumab products. Biosimilars offered in auto-injector devices will likely be more popular than biosimilars that are offered in only prefilled syringes.

The Center for Biosimilars® interviewed Carina Dolan, PharmD, MS, BCOP, senior director for clinical oncology and pharmaceutical outcomes at Vizient about the report for a podcast episode of Not So Different. Dolan weighed in on how health systems can prepare for more adalimumab biosimilars to enter the market and improve patient confidence in biosimlars as well as how pharmacy benefit managers may choose to place adalimumab biosimilars on formulary lists.

Confidence in Physicians and Infliximab Adherence

An Australian study showed that patients with RA and IBD had comparable positive outlooks towards biologics, reporting that they felt that they could trust their specialists’ recommendations about biologic and biosimilar drugs.

The study included responses from 838 individuals. Although most were not very familiar with biologic and targeted synthetic disease modifying agents, recommendations from a specialists was the most frequent factor that prompted patient to change from an originator to a biosimilar.

An analysis of US claims data found the adherence rates were higher among patients who have been using Remicade (reference infliximab) since 2017 compared with patients who have been using an infliximab biosimilar since 2017. The study also found that prevalent Remicade users had better adherence than patients who were new starts to Remicade or an infliximab biosimilar.

Other factors that impacted infliximab adherence were age, depression, a hospitalization, and using another biologic drug. Additionally, patients with IBD had higher adherence rates than patients with RA.